Legislation Details
- Full Title: Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments
- Law Type: Federal Decree-Law
- Law Number: [number] of 2024
- Issued Date: 01 Oct 2024
- Effective Date: 02 Jan 2025
- Official Gazette: No. 785
- Sector: Healthcare
- Status: Active
- Number of Articles: 457
- Chapters/Parts: 0
- Amendments: 0
Summary
This Federal Decree-Law regulates the medical products industry in the UAE, including the approval, manufacturing, distribution, and promotion of pharmaceutical and medical products. It also governs the licensing and practice of pharmacists and pharmaceutical establishments. The law aims to ensure the safety, efficacy, and quality of medical products available in the UAE market, as well as promote the local pharmaceutical industry. It is a comprehensive piece of legislation that impacts businesses and individuals involved in the healthcare and pharmaceutical sectors in the UAE. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024)
What is the scope and purpose of this law?
The scope of this Federal Decree-Law is to regulate the medical products industry in the UAE, including the approval, manufacturing, distribution, and promotion of pharmaceutical and medical products. It also governs the licensing and practice of pharmacists and pharmaceutical establishments. The purpose of the law is to ensure the safety, efficacy, and quality of medical products available in the UAE market, as well as promote the local pharmaceutical industry. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 1-2)
What are the key definitions under this law?
The law provides the following key definitions:
- State: The United Arab Emirates
- The Ministry: Ministry of Health & Prevention
- The EDE: The Emirates Drug Establishment
- Minister: Minister of Health & Prevention
- Board of Directors (BOD): The Emirates Drug Establishment Board of Directors
- Chairman: EDE Chairman BOD
- Competent Health Entity: Any local government body concerned with health affairs, each within their jurisdiction
- Medical Product: The product described in Article 2
- Pharmaceutical Product: Any product that contains an active substance or group of active substances that achieves the intended purpose of use thereof in or on the human or animal body through a biological effect
- Biopharmaceutical Products: Pharmaceutical Products obtained by biotechnology from a living organism
- Advanced Medical Treatment Products: Pharmaceutical Products based on modern and innovative technologies such as gene and cell therapy, stem cell therapy, genetic engineering, and engineered tissues
- Local Product: A Pharmaceutical Product that has obtained Marketing Approval from the Marketing Rights holder within the State and is manufactured in local factories
- Food Supplements: Products taken orally that support the human diet and do not treat, diagnose, or prevent diseases
- Cosmetics: Products with a medical effect that are used on the human body to produce a desired local effect on the skin, hair or nails
- Innovative Product: A Pharmaceutical Product that is the first of its kind in its category
(Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 1)
What are the main obligations and requirements?
The key obligations and requirements under this law include: 1. Obtaining marketing approval from the EDE for any medical product before it can be circulated in the UAE market. The law specifies the terms and conditions for granting marketing approval, including validity and renewal periods. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 3-17) 2. Appointing pharmaceutical establishments to be responsible for the marketing, distribution, and post-marketing surveillance of medical products. The law outlines the obligations of these appointed establishments. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 22-23) 3. Complying with good manufacturing practices and quality management standards for the production of medical products. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 27-28) 4. Obtaining approvals or permits from the EDE for the import, export, and safe disposal of medical products and raw materials. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 31-51) 5. Adhering to specific requirements for the circulation and sale of prescription and non-prescription medical products. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 40-41)
What licensing, registration, or approval requirements exist?
The law establishes various licensing requirements for pharmaceutical establishments and related entities: 1. General pharmacies and pharmacy chains must obtain a license to operate, with specific conditions and prohibitions. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 83-91) 2. Compound pharmacies must obtain a separate license to operate, with their own set of conditions and prohibitions. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 92-97) 3. Medical warehouses and medical stores must obtain a license to operate, with specific requirements. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 98-103) 4. Marketing offices for medical products must obtain a license, with conditions and prohibitions. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 106-112) 5. Pharmaceutical consulting offices must obtain a license to operate. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 113-118) 6. Pharmaceutical laboratories, medical product factories, research and development companies, biobanks, and bioequivalence centers must all obtain specific licenses to operate. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 119-158)
What rights and protections does this law provide?
The law provides the following key rights and protections: 1. It protects the intellectual property rights of medical product marketing rights holders. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 18) 2. It grants the marketing rights holder certain obligations and responsibilities, including appointing pharmaceutical establishments to handle the marketing, distribution, and post-marketing surveillance of their products. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 21-23) 3. It allows for personal use of medical products, subject to certain conditions. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 35) 4. It establishes a national policy for maintaining strategic stocks of essential medical products. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 43) 5. It grants pharmacists certain rights and duties in the practice of their profession, including the right to dispense prescriptions and the duty to report adverse events. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 73-82)
Which authorities or bodies are responsible for enforcement?
The key authorities and bodies responsible for the enforcement of this law are: 1. The Ministry of Health & Prevention (the Ministry): The Ministry is responsible for overseeing the implementation of this law and issuing the necessary executive resolutions. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 176) 2. The Emirates Drug Establishment (EDE): The EDE is responsible for a wide range of regulatory functions, including granting marketing approvals, issuing licenses, and overseeing the pharmaceutical industry in the UAE. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 1, 36, 65-67, 179) 3. The Drug Policy Committee: This committee is established under the law to advise the EDE on matters related to medical product policies and regulations. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 36) 4. Judicial Police Officers: The law empowers certain officials to act as judicial police officers and enforce the law's provisions. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 172)
What are the penalties for non-compliance?
The law prescribes the following penalties for non-compliance: 1. Imprisonment for a period of not less than 6 months and not exceeding 5 years, and/or a fine of not less than AED 100,000 and not exceeding AED 1,000,000 for the following violations: - Counterfeiting or forging medical products or their packaging. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 164) - Importing, exporting, or circulating medical products without obtaining the required approvals or permits. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 165) 2. Imprisonment for a period of not less than 3 months and not exceeding 3 years, and/or a fine of not less than AED 50,000 and not exceeding AED 500,000 for the following violations: - Promoting or advertising medical products without the required approvals. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 166) - Practicing the profession of pharmacy without a valid license. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 167) 3. Additional penalties may include the revocation of licenses, closure of establishments, and deportation of offenders. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 168-169)
How does this law interact with other UAE legislation?
This Federal Decree-Law interacts with several other UAE laws and regulations, including: 1. Federal Law No. (1) of 1972 Concerning the Competences of Ministries and the Powers of Ministers, as amended. 2. Federal Law No. (4) of 2015 Concerning Private Health Establishments, as amended. 3. Federal Decree-Law No. (4) of 2016 Concerning Medical Liability, as amended. 4. Federal Law No. (9) of 2017 Concerning Veterinary Preparations. 5. Federal Law No. (8) of 2019 Concerning Medical Products, Pharmacists and Pharmaceutical Establishments, as amended. 6. Federal Law No. (11) of 2021 Regulating and Protecting the Industrial Property Rights. 7. Federal Law No. (30) of 2021 Combating Narcotics and Psychotropic Substances, as amended. 8. Federal Decree-Law No. (32) of 2021 Concerning Commercial Companies. 9. Federal Law No. (3) of 2022 Regulating the Commercial Agencies. 10. Federal Decree-Law No. (28) of 2023 Establishing the Emirates Drug Establishment (EDE). 11. Federal Decree-Law No. (49) of 2023 Regulating the Use of the Human Genome. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Preamble)
When did this law come into effect?
This Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments was issued on 01 October 2024 and came into effect on 02 January 2025. (Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments, 2024, Art. 181)
Source Documents
This article analyses Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.